FDA’s Regulation of Nanotech: a Change in the Wind?

FDA’s approach to regulation of nanotechnology has remained essentially unchanged since the issuance of the agency’s Nanotechnology Task Force Report in 2007. In that report, which was endorsed by then-Commissioner von Eschenbach, FDA declined to adopt a formal definition of nanotechnology, and also declined to recommend nanotechnology-specific regulations – opting instead for the issuance of guidance documents intended to foster predictability and increase transparency. However, an influx of new blood in the Office of the Commissioner, together with an overall shift to a more muscular exercise of the agency’s existing authorities, suggests that advocates of tighter regulatory oversight might yet get their wish.

Starting at the top, Commissioner Margaret Hamburg previously served on the Advisory Board for the Project on Emerging Nanotechnologies ("PEN"). PEN has consistently questioned whether the government’s oversight of nanotechnology is adequate to anticipate and manage potential human health and environmental risks. Dr. Jessie Goodman, Deputy Commissioner for Science and Public Health, now serves as the agency’s principal representative on nanotechnology (a role formerly played by Dr. Norris Alderson, former Associate Commissioner for Science and Health Coordination and leader of the Nanotechnology Task Force, who is no longer with the agency). Michael Taylor has rejoined the agency as Deputy Commissioner for Foods. Mr. Taylor previously authored a report concluding in part that there are gaps in FDA’s existing legal authorities that could impede the agency’s effective regulation of nanotech-derived products. Finally, as the agency’s new Chief Counsel, Ralph Tyler has indicated that he is likely to be more supportive of an expansive view of the FDC Act than were his immediate predecessors. Taken together, this is a leadership team that seems more inclined to venture where the previous administration opted not to tread.

As the deck was being reshuffled at FDA, other jurisdictions and agencies have been moving to establish more comprehensive oversight of nanotech-derived products. For example, earlier this year, Health Canada adopted a “working definition” of nanotechnology that “will be applied in specific regulatory contexts across the Department to support the assessment of nanomaterials and to provide assistance to manufacturers and other stakeholders in meeting their respective statutory obligations.” Further, Health Canada made clear that it considers its existing authorities adequate “to require the submission of information that is essential to the assessment of potential risks to the health and safety of Canadians,” and that the Department intends to “apply the appropriate precautionary approaches as may be warranted.” Closer to home, PEN reports that EPA has adopted its own “working definition” of nanotechnology, and has indicated that it expects to publish a Federal Register notice in June that will address nanotechnology. The notice will announce a new interpretation of FIFRA and its implementing regulations, under which “the presence of a nanoscale material in a pesticide product” will be considered reportable under that statute. Given these developments, it would not be surprising to see FDA’s new leadership also move to assert tighter control over nanotech-derived products that fall under its jurisdiction.